Clinical Research Associate

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Tigermed

Clinical Research Associate - CRA (Level Depending on Experience)

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close‑out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH‑GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

Responsibilities

Site Management

• Study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
• Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
• Ensure Principal Investigator / study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH‑GCP and GCP.
• Track study recruitment to ensure recruitment target is achieved in all studies.
• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start‑up and throughout the study.
• Assemble site specific EC submission dossier, and ensure submission to EC.

Training

Documentation

Drug Safety

Finance and Administration

Study Tools and System

Qualifications

Seniority level : Associate

Employment type : Full‑time

Job function : Research

Industry : Pharmaceutical Manufacturing

#J-18808-Ljbffr